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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03299673
Other study ID # 2017-HAL-EL-75
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2017
Est. completion date December 5, 2018

Study information

Verified date November 2023
Source Elpen Pharmaceutical Co. Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The present non-interventional observational study in the Greek population aims at collecting the characteristics of COPD patients selected to be given the inhaled combination of fluticasone propionate and salmeterol in doses of 100 μg mcg (250 μg) mcg (500 g) mcg through the Elpenhaler® device, to investigate (a) the effectiveness of the treatment for compliance and the quality of life of the patients; and (b) the safety of the drugs in patients whose disease is treated either in a hospital or in a private physician.


Description:

Rolenium® is an inhalable combination the active ingredients of which is the inhaled combination of fluticasone propionate and salmeterol in doses (100 + 50) mcg, (250 + 50) mcg, (500 + 50) mcg administered via the Elpenhaler ®, developed by ELPEN. It has been approved as a bronchodilator therapy for COPD (a fast-exiting volume in the first second (FEV1) after a bronchodilator less than 60% predicted) with a history of repeated seizures that have significant symptoms despite regular bronchodilator therapy. For COPD in adults an inhalation of 500 micrograms of fluticasone propionate and 50 micrograms of salmeterol twice daily is recommended4. More information on the efficacy and safety of the investigational medicinal product is provided in the Summary of Product Characteristics (SPC).


Recruitment information / eligibility

Status Completed
Enrollment 600
Est. completion date December 5, 2018
Est. primary completion date December 5, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Patients to be started on Rolenium®, an inhaled combination of fluticasone propionate and salmeterol in doses (100 + 50) mcg, (250 + 50) mcg, (500 + 50) mcg administered via the Elpenhaler® - Patients who should be diagnosed with severe COPD and FEV1 <60% of the expected normal rate and a history of repeated exacerbations that have significant symptoms despite regular bronchodilator therapy: 1. Single LABA bronchoconstriction 2. Under dual bronchoconstriction LABA / LAMA 3. Never have received inhaled or systemic corticosteroids (ICS) 4. Previous ICS use in the past may be present, as long as the patient is not in the same treatment for the last three months. - Male or female patients over 18 years of age - Compliance with treatment - Compliance with study procedures - Signed informed consent form Exclusion Criteria: - Men or women under 18 years of age - Non-compliance with treatment - Inappropriate use of inhaled therapies - Non-compliance in study procedures - Unsigned patient consent

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Greece Evagelismos hospital Athens

Sponsors (1)

Lead Sponsor Collaborator
Elpen Pharmaceutical Co. Inc.

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
Primary Compliance Change in MMAS-8 item scale 3 months
Secondary Quality of Life Change in CCQ scale 3 months
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